MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

February 19, 2025 updated by: Zhen Zhang, Fudan University

A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-70 years old, male or female
  2. Pathologically confirmed rectal adenocarcinoma
  3. The distance from anal verge ≤ 10 cm
  4. Clinical stage T3-4 and/or N+
  5. No evidence of distance metastases
  6. MSI/MMR status: MSS/pMMR
  7. Karnofsky score >=70
  8. Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy
  9. No chemotherapy or any other anti-tumor therapy prior to enrollment
  10. No immunotherapy prior to enrollment
  11. With good compliance during the study
  12. Signed written informed consent

Exclusion Criteria:

  1. Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
  2. Pregnancy or breast-feeding women
  3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
  4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
  5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
  6. Individuals with autoimmune diseases
  7. Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases
  8. Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB <1.5 times the upper limit of normal; Cr <1 time the upper limit of normal; Alb ≥30g/L
  9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
  10. Individuals allergic to any drug component of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
The patients will receive conventional pelvic radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT.
Drug: PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Other Names:
  • Toripalimab
Drug: Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Drug: Capecitabine
Capecitabine: 1000mg/m2 bid d1-14 q3w
Experimental: Group B
The patients will receive lymph node-sparing radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT.
Drug: PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
Other Names:
  • Toripalimab
Drug: Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Drug: Capecitabine
Capecitabine: 1000mg/m2 bid d1-14 q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR) rate
Time Frame: 1 month after the surgery
Rate of pathologic complete response (pCR) after surgery
1 month after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3-4 adverse effects rate
Time Frame: From the date of randomization until 3 months after the completion neoadjuvant therapy
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
From the date of randomization until 3 months after the completion neoadjuvant therapy
Anal function
Time Frame: From the date of randomization until 36 months after the surgery
Anal function will be evaluated using LARS score
From the date of randomization until 36 months after the surgery
Surgical complication
Time Frame: The surgical complications were assessed within 3 months after the surgery
Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
The surgical complications were assessed within 3 months after the surgery
3-year local recurrence free survival (LRFS) rate
Time Frame: From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months
Rate of 3-year local recurrence free survival
From the date of randomization until the date of first documented pelvic failure, assessed up to 36 months
3-year disease free survival (DFS) rate
Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Rate of 3-year disease free survival
From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
3-year overall survival (OS) rate
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 36 months
Rate of 3-year overall survival
From the date of randomization until the date of death from any cause, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Estimated)

August 12, 2026

Study Completion (Estimated)

February 12, 2027

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-2024-293-3847

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced Rectal Cancer

Clinical Trials on PD-1 antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe